Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,242
- 试验地点
- 140
- 主要终点
- Primary Effectiveness Endpoint (Randomized IDE Cohort)
研究概览
简要总结
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.
详细描述
The PORTICO pivotal IDE trial will include a randomized cohort of 750 subjects enrolled at up to 70 investigational sites in the United States and Australia. Patients will be randomized (1:1) to receive the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) or any FDA-approved, commercially-available Transcatheter Aortic Valve Replacement (TAVR) System. The randomized cohort will be tested for two co-primary endpoints at 30 days (primary safety endpoint) and 1 year (primary effectiveness endpoint). At the time of the primary randomized cohort analysis, the risk cohorts will be combined and analysis will be conducted on the intention-to-treat (n=750) population.
The FlexNav Delivery System study will be conducted as a separate arm of the PORTICO IDE trial and will include up to 200 high or extreme risk subjects; including a minimum of 100 analysis subjects. The study will characterize the safety of the next-generation Portico Delivery System ("FlexNav™ Delivery System"). The primary analysis cohort will include FlexNav analysis subjects.
The IDE Valve-in-Valve registry will enroll up to 100 high or extreme risk subjects with a failed surgical bioprosthesis who are eligible to receive a Portico Transcatheter Heart Valve.
All subjects enrolled in the PORTICO pivotal IDE trial will undergo follow-up at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 12-months and then annually through 5-years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Effectiveness Endpoint (Randomized IDE Cohort)
时间窗: One-year from randomization
A composite of all-cause mortality or disabling stroke at one year.
Primary Safety Endpoint (Randomized IDE Cohort)
时间窗: 30 days from randomization
Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days.
Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study)
时间窗: 30 days from index procedure
Valve Academic Research Consortium (VARC) 2- defined major vascular complications
次要结局
- Percentage of Patients With Composite Safety Endpoint (Nested Valve-in-Valve Registry)(30 days from index procedure)
- Percentage of Patients With All-cause Mortality or Disabling Stroke (Nested Valve-in-Valve Registry)(One year from index procedure)
- Percentage of Patients With Moderate or Severe Aortic Regurgitation (Randomized IDE Cohort)(One year)
- Six-Minute Walk Test- Total Distance Walked (Randomized IDE Cohort)(One year)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (Randomized IDE Cohort)(One year)
- Percentage of Patients With Severe Aortic Regurgitation (Randomized IDE Cohort)(One year)